The FDA gave the composers a period of grace to finish their production of drugs after the end of the shortage. The small pharmacies had until February 18 to comply, while the largest outsourcing facilities had until March 19. (The semaglutide compounds were ordered to stop mass production this spring, with smaller compounds giving a deadline of April 22 and outsourcing installations until May 22.)
While many composition pharmacies and remote anti -service providers have interrupted production and sales, others have continued to offer shooting products with additional ingredients, unprepared doses or in different forms, like oral versions. “It's a minority,” said Jayne Hornung, head of the Mmit pharmaceutical analysis clinic.
Hornung says that companies that continue to sell shooting hope that vitamin additives and other adjustments will allow them to assert that they do not sell simple copies of patented drugs from Lilly. “They become very creative,” she says.
Composition pharmacies are generally authorized to create personalized drugs for patients even when they are not in shortage, as for people who can be allergic to certain ingredients or need carefully calibrated doses. The node of Lilly's argument is that, with regard to shooting, the teleta companies of drugs are not really personalized because they are produced en masse and prescribed to many patients.
“There are means for compounds to adapt a drug to the patient, for example by adding another ingredient that could help with a side effect or an additional concern or diagnosis,” explains Annie Lambert, pharmacist and clinical programs manager of the Wolters Kluwer Information Service Company. “But there must be good science and evidence behind the safety of the combination of these things.”
The mass composed versions of existing drugs with additives were not widespread until recently, according to Nicole Snow, a pharmacist of the Olympia Pharmaceuticals composition company, who previously produced the composed Tizepatid but arrested after the end of the shortage and never included additives. “We have seen it from time to time, but not in this magnitude,” she says. “It was not a very popular thing until we entered GLP-1.”
In his pursuit against Mochi, Eli Lilly says that the Télésanté company “switched dosages and orders for mass patients at least five times – with business interests, rather than the decision -making decision – by driving changes”.
These changes, according to Lilly, included the creation of two new formulas containing an additive and a pyridoxine of niacinamide, the two forms of vitamin B which, according to the pharmaceutical company, have not proved to be safe or effective when combined with Tizepatid. Mochi's own composition, Aequita Pharmacy, has manufactured some of these products. In March, Washington State regulators ordered the production of being Stop at the Aequita pharmacyCiting security violations linked to GLP-1 drugs.
In another trial brought by the same California court, Lilly says that Fela & Delilah Health changed all her patients from a shooting product composed without additives to a version containing additives of amino acids not tested at the end of last year.
The trial of the pharmaceutical giant against Henry Meds, which offers GLP-1 oral and injectable drugs, accuses the company of “creating false impression” that clinical trials have confirmed the effectiveness of its drugs, “by omitting significantly that there is no clinical data data”.
